A Novel Endoscopic Attachment Cap for Benign Esophageal Stricture Dilation in Children: a Randomized, Multicentric Pilot Study

What this Trial Is About

This research aims to evaluate the safety and effectiveness of the BougieCap device for stretching narrow areas in the esophagus (food pipe) in children. The study compares the BougieCap with traditional dilation methods such as Savary-Bougie or balloon dilation. The goal is to determine if the BougieCap works better, is easier to use, and causes fewer problems or discomfort for children with benign esophageal strictures. Participants are randomly assigned to one of two groups: one group using the BougieCap attached to an endoscope that allows direct visual and tactile control during dilation, and the other group receiving standard treatment with either Savary-Bougie dilation or balloon dilation under endoscopic or radiological control. These treatments involve gradually widening the narrow esophageal areas using different techniques and sizes of dilators or balloons. During the study, participants will answer questions about their symptoms before treatment, 24 hours after, and 14 days later, either during regular hospital visits or over the phone. Researchers will monitor the success of the dilation immediately after the procedure and assess any adverse events, such as bleeding or infections. The study does not add extra risks or burdens for participants and continues until December 2026.

An Innovative Endoscopic Cap for Dilating Benign Esophageal Strictures in Children